What are the key concepts regarding process of care measures and infection control?

Process of care refers to an evidence based action or intervention performed during the delivery of patient care. Process of care measures reflect a healthcare facilities' ability to execute and comply with recommended best patient care practices. Infection control process measures provide actionable and measurable indicators for performance improvement, and provide opportunities to reduce risk healthcare associated infections (HAIs).

What process of care principles are necessary for effective infection control?

Key principles related to process of care measures are:

Measurement and feedback impact compliance

Active interventions are required to produce a change in compliance

Different feedback strategies may lead to distinctively different outcomes

Measuring the benefit seen by the improvement in the process can result in improved HAI rates

Measuring change in compliance with infection control process measures and providing feedback to healthcare workers is critical for success.

What are the conclusions of clinical trials or meta-analyses related to process of care measures that guide infection control practices?

Although there are no meta-analysis or randomized control trials related to process of care measures for infection control available, there are numerous observational and cross sectional studies published that test and, in some cases, demonstrate the effectiveness of this performance improvement strategy to improve compliance.

Processes of care measures for infection control are direct application of risk reduction interventions from clinical outcomes trials.

What are the consequences of ignoring key process of care principles regarding infection control?

What other information supports the research regarding process of care measures and infection control, e.g., case control studies and case series?

Performance monitoring and feedback of infection control process measures is an important tool for improving evidence-based practice. The improvement in compliance with infection control process measures correlates with reduction of healthcare associated infections in some but not all populations and for some but not all sites of infections. Different feedback strategies may lead to differing outcomes.

Successful implementation of process of care measures must often be multifaceted and appropriate to different cultural and social needs.

Summary of current controversies.

Controversy exists as to whether meticulous surveillance and feedback of process of care measures will fully increase adherence to recommended best practices and result in a concomitant reduction or eliminating HAIs.

Application interventions from observational studies remain controversial. Potential biases in the original clinical outcome studies are a concern. Owing to the diversity of both process of care study designs and populations, definitive conclusions are problematic and results may not be generalized to all patient populations.

Overview of important clinical trials, meta-analyses, case control studies, case series, and individual case reports related to infection control and process of care measures.

See Table I for a summary of the published studies that assess process of care measures.

Table I.

Published studies assessing process of care measures for infection control

Controversies in detail.

Surveillance for outcome measures is problematic. The preventable fraction of HAIs is not known therefore making it difficult to evaluate if infection prevention measures are adequate in any given patient care unit or facility. Some of the limitations of outcome-based infection surveillance may be addressed by performing surveillance and feedback for infection prevention processes of care measures. The use of central venous or urinary catheter insertion and maintenance practices that have been proven to reduce the rate of device associated infections. First, these measures provide unambiguous performance targets for infection prevention risk reduction and allow for focused prevention efforts.

In addition, as process of care are measures are common events relative to infections, these allow for simple detection of significant deviations in adherence easier to detect then would be significant deviations in outcomes.

Lapses in infection control may then be easier and faster to detect then variances in outcome rates and can be ideally addressed before an increase in infection rates has occurred.

However, for some infection control process of care measures, studies have shown that that adherence to these quality measures is not necessarily associated with improved outcomes. An example is Medicare's 25 quality metrics. Adherence to these processes was thought to lead to improved outcomes. The Surgical Care Improvement Project (SCIP) was introduced in 2006, with the goal of reducing surgical complications and infections by 25% by 2010. (Livington) Based on observational studies demonstrating associations between process and outcome, experts concluded that adherence to these process measures would result in better care. Medicare adopted these and published them on its Hospital Compare website (R) as measures of hospital quality.

Surprisingly, there has not been an improved outcome with the process measure for perioperative antibiotic use and the outcome of postoperative wound infection nor for the outcome of pneumonia. Adherence to process of care measure is also an issue when clinicians and healthcare personnel are not convinced guidelines are evidence-based and therefore scientifically valid. Consequently, they may simply disagree and refuse to follow the process of care measures recommended.

Thus, Process of care measures for infection need to be supported by clinical studies. Clinical outcomes (e.g. ventilator-associated pneumonia) have been firmly established by randomized controlled trials (RCT).The correlation between multiple variables (i.e. process measures) and long term clinical outcomes (e.g., catheter-associated bloodstream infection) has been established by RCT. But process of care measures and short term indicators though well correlated with clinical outcomes cannot always detect the magnitude of difference.

What national and international guidelines exist for process of care measures and infection control?

The most significant International Guidelines that include process of care measures for infection control are written by the World Health Organization (e.g., Practical Guidelines for Infection Control in Health Care Facilities and Hand Hygiene, etc.) and nationally the Centers for Disease Control and Prevention (CDC)'s Hospital Infection Control Practices Advisary Committee (HICPAC) (e.g., Guidelines for Hand Hygiene in Healthcare Facilities). Professional organizations that have contributed guidelines or position papers include: the Association of Professional in Infection Control and Epidemiology (APIC), the Society of Healthcare Epidemiology of America (SHEA), the Surgical Infection Society (SIC), the Infectious Disease Socity of America (IDSA), the Pediatric Infectious Disease Society (PIDS), as well as governmental and regulatory agencies including: the Centers for Medicare and Medicaid (CMS), The Joint Commission (TJC), and the Occupational Safety and Health Organization (OSHA) all with a focus on HAI control and prevention use the expertise of their members and staff to develop and publish a wide variety of useful recommendations and guidelines containing process measures for infection control.

What other consensus group statements exist and what do key leaders advise?

Beginning 30 years ago, professional organizations dedicated to infection control (e.g., APIC. SHEA, IDSA) and government agencies (e.g., CDC, OSHA, CMS, FDA, EPA) began working together to create consensus guidelines that have resulted in numerous CDC HICPAC Guidelines for Health Care settings that set process of care recommendations to include: the primary HAI sites of infection (bloodstream, surgical site, pneumonia, and urinary tract), environmental cleaning and sanitation, disinfection and sterilization, and isolation precautions for communicable diseases (norovirus, MDROs, influenza). The CDC Guidelines and Professional Societies' consensus papers are developed from review of the evidence-based literature, and provide the basis on which standards process of care measures are used for developing institutional healthcare policies and procedures. The use of process measures as performance indicators has been proposed in HICPAC CDC Guidelines.